MERIDIAN BIOSCIENCE, INC. Refer to "Forward-Looking Statements" following the Table of Contents in front of this Form 10-Q. In the discussion that follows, all dollar amounts are in thousands (both tables and text), except per share data. The purpose of Management's Discussion and Analysis is to provide an understanding of the financial condition, changes in financial condition and results of operations ofMeridian Bioscience, Inc. ("Meridian", the "Company", "We"). This discussion should be read in conjunction with the Condensed Consolidated Financial Statements and notes. It should be noted that the terms revenue and/or revenues are utilized throughout the Management's Discussion and Analysis of Financial Condition and Results of Operations ("MD&A") to indicate net revenue and/or net revenues. In addition, throughout the MD&A, we refer to certain product tradenames and trademarks, which are protected under applicable intellectual property laws and are our property. Solely for convenience, these tradenames and trademarks are referred to without the ® or ™ symbols, but such references are not intended to indicate in any way that we will not assert, to the fullest extent of the law, our rights to these tradenames and trademarks.
Reportable Segments
Our reportable segments are Diagnostics and Life Science. The Diagnostics segment consists of manufacturing operations for infectious disease products inCincinnati, Ohio ;Quebec City, Canada ; and Modi'in,Israel ; and manufacturing operations for blood chemistry products inBillerica, Massachusetts . These diagnostic test products are sold and distributed in the countries comprisingNorth and Latin America (the "Americas");Europe ,Middle East andAfrica ("EMEA"); and other countries outside of theAmericas and EMEA (rest of the world, or "ROW"). The Life Science segment consists of manufacturing operations inMemphis, Tennessee ;Boca Raton, Florida ;North Brunswick, New Jersey ;London, England ; andLuckenwalde, Germany , and the sale and distribution of bulk antigens, antibodies, immunoassay blocking reagents, various Polymerase Chain Reaction ("PCR") and isothermal amplification master mixes, and bioresearch reagents domestically and abroad, including a sales and business development facility, with outsourced distribution capabilities, inBeijing, China to further pursue growing revenue opportunities inAsia . Page 19
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Table of Contents Recent Developments Agreement and Plan of Merger OnJuly 7, 2022 , the Company entered into an Agreement and Plan of Merger (as it may be amended, supplemented or otherwise modified from time to time, the "Merger Agreement") with SD Biosensor, Inc., a corporation with limited liability organized under the laws of theRepublic of Korea ("SDB"),Columbus Holding Company , aDelaware corporation ("Parent"), andMadeira Acquisition Corp. , anOhio corporation and a direct wholly owned subsidiary of Parent ("Merger Sub," and together with SDB and Parent, the "Parent Parties"). Pursuant to the Merger Agreement, Merger Sub merged with and into Meridian (the "Merger"), with Meridian surviving the Merger as a direct wholly owned subsidiary of Parent. OnDecember 9, 2022 , Meridian and the Parent Parties entered into a Letter Agreement (the "Letter Agreement"), modifying the Merger Agreement, such that all of the conditions to the Parent Parties' obligation to complete the Merger have been satisfied (and are deemed to remain satisfied through the completion of the Merger), provided that Meridian is required to comply with certain covenants in the Merger Agreement through the completion of the Merger. Under the Letter Agreement, Meridian and the Parent Parties also agreed to, among other things, consummate the Merger onJanuary 31, 2023 . OnJanuary 31, 2023 , the Merger was consummated in accordance with the terms of the Merger Agreement and the Letter Agreement, and Parent, which at the time of Closing was wholly-owned and controlled by SDB, became the sole shareholder of Meridian. Pursuant to the terms of the Merger Agreement, at the effective time of the Merger, each issued and outstanding share of Meridian's common stock (subject to certain exceptions set forth in the Merger Agreement) was canceled and converted into the right to receive$34.00 in cash, without interest (the "Merger Consideration"). See Note 18, "Subsequent Events" of the Condensed Consolidated Financial Statements regarding consummation of the Merger. The foregoing description of the Merger, the Merger Agreement, and the Letter Agreement does not purport to be complete and is subject to, and qualified in its entirety by, the full text of (i) the Merger Agreement, a copy of which was filed by Meridian as Exhibit 2.1 to Meridian's Current Report on Form 8-K filed onJuly 7, 2022 and is incorporated herein by reference, and (ii) the Letter Agreement, a copy of which was filed by Meridian as Exhibit 2.1 to Meridian's Current Report on Form 8-K filed onDecember 12, 2022 and is incorporated herein by reference.
The Company incurred transaction related costs of approximately
Impact of COVID-19 Pandemic
Starting in the latter half of fiscal 2020 and continuing to the date of this
filing, the ongoing COVID-19 pandemic has had both positive and negative effects
on our business.
Our Life Science segment's products were well positioned to respond to in vitro
device ("IVD") manufacturers' increased demand for reagents used in the
manufacture of molecular, rapid antigen and serology tests. Consequently,
through the end of the second quarter of fiscal 2022, our Life Science segment
consistently delivered significantly higher levels of net revenues and operating
income than those achieved prior to the COVID-19 pandemic, with the peak to date
in such levels occurring during the second quarter of fiscal 2022. This revenue
peak has been followed by a significant decrease in such net revenue levels
since the second quarter of fiscal 2022, reflecting the softening in demand for
COVID-19 related reagents.
Our Diagnostics segment, on the other hand, has generally been negatively
impacted by health systems' increased focus on COVID-19 testing over traditional
infectious disease testing. Revenues from our respiratory illness assays were
most dramatically impacted by the COVID-19 pandemic. However, we are continuing
to experience what we believe to be a continuation of a return to pre-pandemic
activity levels.
There continues to be many uncertainties surrounding the COVID-19 pandemic, and we can provide no assurances with respect to our views of the longevity or severity of the positive or negative impacts to our consolidated financial condition of the ongoing COVID-19 pandemic.
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Employee Safety
While the majority of our employee base has returned to working on-site at our facilities, we have implemented a hybrid work-from-home program for certain personnel whose on-site presence has been deemed to be non-essential. We also continue to utilize enhanced cleaning and sanitizing procedures, and provide additional personal hygiene supplies at all our sites. We have implemented policies for employees to adhere toCenters for Disease Control and Prevention ("CDC") guidelines on social distancing, and similar guidelines by authorities outside theU.S. To date, we have been able to manufacture and distribute products globally, and all our sites have continued to operate with little, if any, impact on shipments to customers. As the COVID-19 pandemic continues, along with continuing governmental restrictions which vary by locale and jurisdiction, there is an increased risk of employee absenteeism, which could materially impact our operations at one or more sites. To date, the steps we have taken, including our work-from-home processes, have not materially impacted the Company's financial reporting systems, internal controls over financial reporting or disclosure controls.
Supply Chains
Supply chains supporting our products have generally remained intact, providing access to sufficient inventory of the key materials needed for manufacturing. While we have experienced extended lead times for certain select raw materials, delays and allocations for raw materials have to date been limited and have not had a material impact on our results of operations. From time to time, we identify alternative suppliers to address the risk of a current supplier's inability to deliver materials in volumes sufficient to meet our manufacturing needs; or we may choose to purchase certain materials in bulk volumes where we have supply chain scarcity concerns. It remains possible that we may experience some sort of interruption to our supply chains, and such an interruption could materially affect our ability to timely manufacture and distribute our products and unfavorably impact our results of operations. Since the second half of fiscal 2021, we have experienced input cost inflation, including materials, labor and transportation costs. Pricing actions and supply chain productivity initiatives have mitigated and are expected to continue to mitigate some of these inflationary pressures, but we may not be successful in fully offsetting these incremental costs, which could have an impact on the Company's results of operations and cash flows in the future.
Product Development and Clinical Trials
Our Diagnostics segment's new product development programs are continuing to progress at a slower pace than normal, due in part to the prevalence of certain infectious diseases having been lower than normal during the COVID-19 pandemic. These matters continue to impact our timing for filing applications for product clearances with theU.S. Food and Drug Administration ("FDA"), as well as related timing of FDA clearances of such filings. Additionally, the ongoing COVID-19 pandemic has slowed and could continue to slow down our efforts to expand our product portfolio, impacting the speed with which we are able to bring additional products to market.
Lead Testing Matters
OnSeptember 1, 2021 , the Company's wholly owned subsidiary Magellan announced the expansion of the Class I voluntary recall of its LeadCare test kits for the detection of lead in blood, which it had initiated inMay 2021 after identifying an issue in certain manufactured lots of its LeadCare test kits. As a result of the identified issue, impacted test kit lots could potentially underestimate blood lead levels when processing patient blood samples. Although it was initially believed that the root cause of the issue related to the plastic containers used for the treatment reagent, additional studies have indicated that the root cause related to the third-party-sourced cardboard trays that held the treatment reagent containers. Upon correction of the identified supplier issue, shipment of product resumed during the second quarter of fiscal 2022. The Company continues to work closely with the FDA in its execution of the recall activities, which has included Magellan notifying customers and distributors affected by the recall and providing instructions for the return of impacted test kits. Remaining accrued LeadCare product recall costs totaling approximately$177 and$430 are reflected within the Condensed Consolidated Balance Sheets atDecember 31, 2022 andSeptember 30, 2022 , respectively. Anticipated recall-related costs primarily include temporary labor costs, product replacement and/or refund costs, mailing/shipping costs, attorneys' fees and other miscellaneous costs. Page 21
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OnApril 17, 2018 , the Company's wholly owned subsidiary Magellan received a subpoena from theU.S. Department of Justice ("DOJ") regarding its LeadCare product line. The subpoena outlined documents to be produced, and the Company is cooperating with the DOJ in this matter. The Company maintains rigorous policies and procedures to promote compliance with applicable regulatory agencies and requirements and is working with the DOJ to promptly respond to the subpoena, including responding to additional information requests that have followed receipt of the subpoena inApril 2018 . The Company has executed tolling agreements to extend the statute of limitations. In March andApril 2021 , DOJ issued two subpoenas, both to former employees of Magellan, calling for witnesses to testify before a federal grand jury related to this matter. In September andOctober 2021 , DOJ issued additional subpoenas to individuals seeking testimony and documents in connection with its ongoing investigation. It is the Company's understanding that multiple witnesses have testified before the federal grand jury and the DOJ's investigation is ongoing. Discussions continue with the DOJ to explore resolution of the matter. The Company believes a loss is probable in the DOJ LeadCare legal matter and, in accordance with applicable accounting guidance, has accrued$42,000 and$10,000 as ofDecember 31, 2022 andSeptember 30, 2022 , respectively, as an estimate of the cost to resolve the DOJ LeadCare legal matter. The increase in the estimated cost to resolve the DOJ LeadCare legal matter is based upon additional information received by the Company during discussions held with the DOJ subsequent toSeptember 30, 2022 . The$32,000 expense resulting from the increase in the accrual is reflected in litigation and select legal costs within the Condensed Consolidated Statement of Operations for the three months endedDecember 31, 2022 . The Company cannot predict when the investigation will be resolved or the outcome of the investigation, and the ultimate resolution of the DOJ LeadCare legal matter may exceed the amount accrued atDecember 31, 2022 and could be material to the Company. Approximately$814 and$281 of expense for attorneys' fees related to this matter is included within the Condensed Consolidated Statements of Operations for the three months endedDecember 31, 2022 and 2021, respectively.
RESULTS OF OPERATIONS
Three Months Ended
A net loss of$29,821 , or$0.68 per diluted share, was generated during the first quarter of fiscal 2023, compared to$15,340 of net earnings, or$0.35 per diluted share, during the first quarter of fiscal 2022. The net loss in the first quarter of fiscal 2023 reflects primarily the overall increase in operating expenses described in the Operating Expenses section below, along with the decline in net revenues and operating income in our Life Science segment, stemming from the dramatic softening in demand for COVID-19 related reagents during the quarter.
Consolidated net revenues for the first quarter of fiscal 2023 totaled
Net revenues from the Diagnostics segment for the first quarter of fiscal 2023 increased 19% to$39,366 , compared to the first quarter of fiscal 2022, comprised of a 23% increase in non-molecular assay products, partially offset by a 6% decrease in molecular assay products. The first quarter of fiscal 2023 represents the seventh consecutive quarter our Diagnostics segment has shown positive revenue growth versus the same quarter in the prior fiscal year. Our Diagnostics segment generated$3,160 of operating income in the first quarter of fiscal 2023, compared to an operating loss of$1,763 in the first quarter of fiscal 2022, reflecting the increase in net revenues and gross profit margins, along with relatively flat operating expenses, as described in the respective sections below. With a 76% decrease in net revenues from molecular reagents products and a 58% decrease in net revenues from immunological reagents products, net revenues for our Life Science segment decreased 68% during the first quarter of fiscal 2023 compared to the first quarter of fiscal 2022. Our Life Science segment generated$5,383 of operating income, or a margin of 31%, for the first quarter of fiscal 2023, a decrease of$21,219 from$26,602 , or a margin of 48%, achieved in the first quarter of fiscal 2022. This decrease primarily results the decrease in net revenues and associated gross profit, which result in large part from the aforementioned dramatic softening in demand for COVID-19 related reagents. Page 22
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REVENUE OVERVIEW
Below are analyses of the Company's net revenues, provided for each of the following:
- By Reportable Segment &
- By Product Platform/Type
Revenue Overview- By Reportable Segment &
Revenues for the Diagnostics segment, in the normal course of business, may be affected from year to year by buying patterns of major distributors and reference laboratories, seasonality and severity of seasonal diseases and outbreaks (including the ongoing COVID-19 pandemic), and foreign currency exchange rates. Revenues for the Life Science segment, in the normal course of business, may be affected from year to year by buying patterns of major IVD manufacturing customers, severity of disease outbreaks (specifically the ongoing COVID-19 pandemic), and foreign currency exchange rates. See the "Revenue Disaggregation" section of Note 4, "Revenue Recognition" of the Condensed Consolidated Financial Statements for detailed revenue disaggregation information.
Following is a discussion of the net revenues generated by these product platforms/types and/or disease states:
Diagnostics Segment Products
During the first quarter of fiscal 2023, Diagnostics segment net revenues increased$6,162 , or 19%, compared to the first quarter of fiscal 2022. This growth primarily resulted from the$4,542 increase in net revenues from sales of blood chemistry products, as sales of the LeadCare product have continued to rebound since shipment of the product resumed in the second quarter of fiscal 2022. LeadCare shipments resumed upon correction of the identified supplier issue that caused the LeadCare product recall, which commenced inMay 2021 (see Note 7, "Lead Testing Matters" of the Condensed Consolidated Financial Statements).
Life Science Segment Products
During the first quarter of fiscal 2023, net revenues for our Life Science segment decreased 68% compared to the first quarter of fiscal 2022. While the level of net revenues during the first quarter of fiscal 2023 reflects the significant decline in demand for COVID-19 related reagents, such level of quarterly net revenues significantly outpaced the pre-pandemic level of net revenues generated in the first quarter of fiscal 2020; increasing 39% in total, 41% for molecular reagents and 37% for immunological reagents.
Significant Customers
Revenue concentrations related to certain customers within our Diagnostics and
Life Science segments are set forth in Note 15, "Reportable Segment and Major
Customers Information" of the Condensed Consolidated Financial Statements.
Gross Profit
Three Months Ended December 31,
2022 2021 Change
Gross Profit $ 31,505 $ 49,159 (36 )%
Gross Profit Margin 55 % 56 % -1 point
Overall gross profit margins during the first quarter of fiscal 2023 are
relatively consistent with the fiscal 2022 first quarter margins, with the
slight decline largely reflecting the shift in segment revenue mix. During the
first quarter of fiscal 2023, approximately 31% of consolidated net revenues
were generated from the Life Science segment, the products of which generally
generate higher gross profit margins relative to the Diagnostics segment. This
compares to the Life Science comprising approximately 62% of consolidated net
revenues in the first quarter of fiscal 2022.
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In addition, Diagnostics segment gross profit margins were favorably impacted by the previously discussed resumption of blood chemistry product sales in the second quarter of fiscal 2022 (see "Diagnostics Segment Products" above). This resulted in$4,620 of net revenues from sales of such products in the first quarter of fiscal 2023, compared to only$78 in the fiscal 2022 first quarter.
Operating Expenses - Segment Detail and Corporate
Total
Research & Selling & General & Operating
Development Marketing Administrative Other Expenses
Fiscal 2023 First Quarter:
Diagnostics $ 5,230 $ 6,280 $ 6,010 $ - $ 17,520
Life Science 947 2,014 2,418 28 5,407
Corporate - - 2,645 34,048 36,693
Total 2023 First Quarter Expenses
11,073$ 34,076 $ 59,620 Fiscal 2022 First Quarter: Diagnostics$ 5,556 $ 6,009 $ 6,294 $ -$ 17,859 Life Science 638 1,732 4,076 - 6,446 Corporate - - 4,290 281 4,571
Total 2022 First Quarter Expenses
14,660
Compared to the prior year first quarter, operating expenses increased
• A
Corporate and primarily related to the previously discussed LeadCare
legal matter (see "Lead Testing Matters" above); and
• A
within Corporate and related to the previously discussed merger (see
"Agreement and Plan of Merger" above).
Partially offsetting these increases was a
Operating Income (Loss)
An operating loss of$28,115 was generated in the first quarter of fiscal 2023, compared to$20,283 of operating income during the first quarter of fiscal 2022. These operating income (loss) levels result from the factors discussed above.
Income Taxes
The effective rate for income taxes was (2%) and 22% for the three months endedDecember 31, 2022 and 2021, respectively. The negative effective rate for the three months endedDecember 31, 2022 relates primarily to the anticipated non-deductibility of the previously discussed LeadCare legal matter (see "Lead Testing Matters" above). Impact of Inflation To the extent feasible, we have consistently followed the practice of reviewing our prices to consider the impacts of inflation on salaries and fringe benefits for employees, the cost of purchased materials and services, and transportation costs. Inflation and changing prices did not have a material adverse impact on our gross margin, revenues or operating income (loss) in the first quarter of fiscal 2023 or fiscal 2022. Page 24
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Liquidity and Capital Resources
Liquidity
Our cash flow and financing requirements are determined by analyses of operating and capital spending budgets and debt service. We have historically maintained a credit facility to augment working capital requirements and to respond quickly to acquisition opportunities. We have an investment policy that guides the holdings of our investment portfolio, which presently consists of bank savings accounts and institutional money market mutual funds. Our objectives in managing the investment portfolio are to: (i) preserve capital; (ii) provide sufficient liquidity to meet working capital requirements and fund strategic objectives such as acquisitions; and (iii) capture a market rate of return commensurate with market conditions and our policy's investment eligibility criteria. As we look forward, we will continue to manage the holdings of our investment portfolio with preservation of capital being the primary objective. We intend to continue to fund our working capital requirements from current cash flows from operating activities and cash on hand, and such sources are anticipated to be adequate to fund working capital requirements, capital expenditures and debt service during the next twelve months. However, if needed, we also have an additional source of liquidity through the amount remaining available on our$200,000 bank revolving credit facility, which totaled$175,000 as ofDecember 31, 2022 (see Note 18, "Subsequent Events" of the Condensed Consolidated Financial Statements for a discussion of activities related to the Company's bank credit arrangements occurring subsequent to theDecember 31, 2022 Condensed Consolidated Balance Sheet date). Our liquidity needs may change if overall economic conditions worsen and/or liquidity and credit within the financial markets tightens for an extended period, and such conditions impact the collectability of our customer accounts receivable, impact credit terms with our vendors, or disrupt the supply of raw materials and services. As ofDecember 31, 2022 , our cash and cash equivalents balance was$74,098 or$7,355 lower than atSeptember 30, 2022 . This decrease primarily results primarily from the combined effects of: (i)$2,349 of cash used in operations; and (ii) using cash to acquire property, plant and equipment ($2,654 ) and the assets ofEstel Biosciences, Inc. ($2,000 ) (see Note 6, "Business Combinations" of the Condensed Consolidated Financial Statements). Considering these factors, our balance of cash and cash equivalents on hand exceeded our total debt (defined as bank debt, government grant obligations and obligations related to acquisitions) by approximately$41,800 atDecember 31, 2022 . Capital Resources As described in Note 12, "Bank Credit Arrangements" of the Condensed Consolidated Financial Statements, the Company maintains a$200,000 revolving credit facility, which is secured by substantially all of ourU.S. assets and includes certain restrictive financial covenants. As ofDecember 31, 2022 , the Company was in compliance with all covenants. In addition, as ofDecember 31, 2022 , Meridian maintains a shelf registration statement on file with theSEC . See Note 18, "Subsequent Events" of the Condensed Consolidated Financial Statements for a discussion of activities related to the Company's bank credit arrangements and public company status occurring subsequent to theDecember 31, 2022 Condensed Consolidated Balance Sheet date. During fiscal 2023 our capital expenditures are estimated to total approximately$10,000 , comprised of approximately$6,500 and$3,500 in the Diagnostics and Life Science segments, respectively. Such expenditures may be funded with cash and cash equivalents on hand, operating cash flows, and/or availability under the$200,000 revolving credit facility discussed above.
License Agreements
The Company has entered into various license agreements that require payment of royalties based on a specified percentage of sales of related products. During the first quarter of fiscal 2023, royalty expense totaled approximately$150 , with 70% and 30% of such expense relating to our Diagnostics and Life Science segments, respectively. This compares to a total of approximately$800 of royalty expense in the first quarter of fiscal 2022, with 35% and 65% relating to our Diagnostics and Life Science segments, respectively. The Company expects that payments under these agreements will amount to approximately$700 in fiscal 2023, a decrease from the$2,300 in fiscal 2022, with the anticipated decrease largely resulting from the last of the licensed patents applicable to the Alethia product line having expired during fiscal 2022. Page 25
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Off-Balance Sheet Arrangements
We utilize foreign currency exchange forward contracts to limit exposure to volatility in foreign currency gains and losses related to financial assets denominated in other than the holding subsidiary's functional currency. These contracts are generally settled within a 30-day time frame and are not formally designated or accounted for as accounting hedges. We also utilize interest rate swap agreements to limit exposure to volatility in the LIBOR interest rate in connection with the revolving credit facility. The interest rate swap agreements are designated and accounted for as accounting hedges (see Note 5, "Fair Value Measurements" of the Condensed Consolidated Financial Statements). Aside from these instruments, we do not utilize special-purpose financing vehicles or have any material undisclosed off-balance sheet arrangements.
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